A longitudinal replicate study of immunosuppressive drugs: a College of American Pathologists study.

Abstract:

OBJECTIVE:To identify the sources of analytical variation for cyclosporine and tacrolimus in a 3-year longitudinal study. DESIGN:Two pools of whole blood were spiked with cyclosporine and tacrolimus, respectively. One aliquot of cyclosporine and 2 of the tacrolimus pool were distributed in the first and last mailing for years 1999 to 2001. For both drugs, the total variance for each method was partitioned into within- and between-laboratory components. SETTING:The A and C mailings of the 1999, 2000, and 2001 AACC/CAP [American Association for Clinical Chemistry/College of American Pathologists] Immunosuppressive Drugs (CS) Monitoring Survey. MAIN OUTCOME MEASURES:For each drug, total variance was partitioned into specimen, mailing, year, and interlaboratory effects for each analytical method. PARTICIPANTS:The 292 laboratories for cyclosporine and 177 laboratories for tacrolimus enrolled in the survey from 1999 to 2001. RESULTS:For both cyclosporine and tacrolimus, the major source of imprecision came from within-laboratory factors, which accounted for nearly 85% (range, 77% to 90%) of the total variance. For cyclosporine, the major component of within-laboratory variance was between-mailing, within-year effect, whereas for tacrolimus it was the between-year, within-laboratory variation. CONCLUSION:The major source of long-term survey imprecision for cyclosporine and tacrolimus is within-laboratory factors. The finding that 85% of the total variance was due to within-laboratory variation is similar to other therapeutic drugs.

journal_name

Arch Pathol Lab Med

authors

Steele BW,Wang E,Soldin SJ,Klee G,Elin RJ,Witte DL,College of American Pathologists Study.

doi

10.1043/0003-9985(2003)127<0283:ALRSOI>2.0.CO;2

subject

Has Abstract

pub_date

2003-03-01 00:00:00

pages

283-8

issue

3

eissn

0003-9985

issn

1543-2165

journal_volume

127

pub_type

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